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510(k) K871499

PROTOFLUOR Z by Helena Laboratories — Product Code JKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1987
Date Received
April 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Measurement, Porphyrins
Device Class
Class I
Regulation Number
862.1595
Review Panel
CH
Submission Type

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Other clearances for product code JKJ

  • K893038 — PROTOFLUOR Z (November 17, 1989)
  • K780455 — QUANTITATIVE DETERMINATION OF PORPHYRINS (July 27, 1978)